Director – Quality GCP

Monte Rosa Therapeutics•Boston, MA

4d•Onsite

About The Position

Monte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs through participation on in-house and external cross-functional teams. This role requires an 75% on-site presence. You will work closely with industry leaders in Boston and Basel . Join a diverse, collaborative, and dynamic team that values innovation, teamwork, and a people-centric culture!

Requirements

BS Degree in Chemistry, Pharmacy, Biology or a related life science, or a combination of a BS Degree with relevant Quality and Technical experience.
Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.).
Able to provide solution-minded approach and flexibility to emerging challenges.
Able to appropriately balance priorities plus multi-task against competing priorities.
Proven experience with the desire, and ability to work in a fast-paced, matrixed, start-up environment.
Hands-on leader, able to provide solution-minded approach and flexibility to emerging challenges

Nice To Haves

GLP experience a plus.
Understanding of drug development and program management preferred.

Responsibilities

Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs as well as other GCP quality events (e.g., potential serious breach assessments, CAPAs)
Author key GCP quality SOPs and key reviewer for other quality (GxP) procedures.
Develop a risk-based GCP compliance program.
Support teams in the initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
Develop and provide GCP and other GxP training (as applicable).
Ensure appropriate qualification of vendors and ensure compliant vendor management and regular assessment/audits.
May conduct GCP audits (vendors and sites).
Ensure audit observations are communicated, tracked and remediated.
Provide QA GCP review and feedback on regulatory submissions.
Lead and participate in inspection readiness activities for regulatory inspections – both internally and at clinical sites.
Interface with internal departments and external vendors on a variety of technical/quality subjects.